Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT04303832
Status:
COMPLETED
Last Update Posted:
2020-03-11
First Post:
2020-03-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Exercise Interventions of Eye Muscles Post Strabismus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013285', 'term': 'Strabismus'}, {'id': 'D000550', 'term': 'Amblyopia'}], 'ancestors': [{'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005139', 'term': 'Eyeglasses'}], 'ancestors': [{'id': 'D007909', 'term': 'Lenses'}, {'id': 'D055096', 'term': 'Optical Devices'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-07', 'studyFirstSubmitDate': '2020-03-04', 'studyFirstSubmitQcDate': '2020-03-07', 'lastUpdatePostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in angle of deviation', 'timeFrame': 'pre and post 12 weeks', 'description': 'deviation of the eye in direction rather than its normal position'}], 'secondaryOutcomes': [{'measure': 'change in visual acuity', 'timeFrame': 'pre and post 12 weeks', 'description': 'measure the ability of the eye to see the objects'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Strabismus and amplyobia and physiotherapy eye exercise'], 'conditions': ['Strabismus', 'Amblyopia']}, 'descriptionModule': {'briefSummary': 'It will be hypothesized that:\n\n* Eye exercises have a positive effect on correction of remaining ocular deviation post strabismus surgery.\n* Eye exercises have a positive effect on improving amplyobia.', 'detailedDescription': 'This study applied to determine the effect of physiotherapy exercises on correction the remaining ocular deviation which still present following the strabismus surgery and also its effect on amplyobia.\n\nDifferent type of physiotherapy exercises was applied to experimental group for 12 weeks beside the medical treatment applied post-surgery while the control group received traditional treatment only.\n\nThe near and far angles of ocular deviation were measured before and after the treatment for evaluation of strabismus and measuring visual acuity for evaluation of amplyobia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '5 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients received strabismus operation\n* All types of strabismus surgery will be included\n* They selected from Outpatient Clinic\n* Patients begin the training program after 2 weeks of operation or more than this\n* The patient still suffering from amblyopia post strabismus surgery\n\nExclusion Criteria:\n\n* Muscular disorders that will impair performance during training.\n* Neurological disorders.\n* Malignant conditions.\n* Psychiatric illness, severe behavior or cognitive disorders. Children who can't understand the therapist's instructions and orders."}, 'identificationModule': {'nctId': 'NCT04303832', 'briefTitle': 'Exercise Interventions of Eye Muscles Post Strabismus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Exercise Interventions of Eye Muscles Post Strabismus Surgery', 'orgStudyIdInfo': {'id': 'P.T.REC/012/001903'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'eye exercise group', 'description': 'This group made different types of eye exercises beside the traditional treatment of strabismus which is eye glasses', 'interventionNames': ['Other: eye exercises', 'Device: eye glasses']}, {'type': 'SHAM_COMPARATOR', 'label': 'control group', 'description': 'This group had traditional treatment of strabismus which is eye glasses', 'interventionNames': ['Device: eye glasses']}], 'interventions': [{'name': 'eye exercises', 'type': 'OTHER', 'description': 'Eye exercises for correcting eye deviation', 'armGroupLabels': ['eye exercise group']}, {'name': 'eye glasses', 'type': 'DEVICE', 'description': 'Eye glasses for correcting eye deviation', 'armGroupLabels': ['control group', 'eye exercise group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Cairo University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Amany Abdel Wahid, M.Sc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cairo University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['SAP', 'CSR'], 'timeFrame': 'later on', 'ipdSharing': 'YES', 'description': 'information about statistical analysis and study report will be sheared with other researcher later on', 'accessCriteria': 'for physical therapist and ophthalmologist'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer', 'investigatorFullName': 'Amany Refaat Mohamed Abdel Wahid', 'investigatorAffiliation': 'Cairo University'}}}}